During my work as a cancer patient advocate I have frequently come into contact with healthcare regulatory bodies. One of the most important of these is the European Medicines Agency, the EMA. It is the regulator which licenses new medicines allowing them to be marketed and used to treat patients. In the UK EMA works closely with the Medicines & Healthcare Regulatory Authority (MHRA) which monitors the market to ensure quality and safety are maintained once drugs are available.
When a new drug is being considered by EMA extensive data from laboratory and clinical studies are analysed. It looks at safety, side efffects and their management, and the efficacy of the drug for the healthcare issue it is intended to treat. The most important elements in these data are from clinical trials where the drug is tested in patients, comparing it with either an existing standard therapy or against a placebo, a dummy treatment. It is a rigorous system and you can count on one hand the occasions in 20 years when it has gone wrong and allowed an unsafe drug into the market. The default position when in doubt is to require further evidence before allowing a drug to be marketed. EMA follows similar practices to the USA’s Food & Drugs Administration (FDA). They are the two most respected drug regulatory bodies in the world.
Although it is not yet certain that Brexit means that the UK will no longer be a member of the EMA it has to be considered a probability. It is already decided that EMA will leave its base in London. What would leaving EMA mean for us?
After Brexit the MHRA will be given the responsibility for licensing new drugs for the UK market. It is easy to see that EMA and MHRA could both be undertaking the same review of the same evidence for the same new drug simultaneously – thus doubling the overall cost of the process. Costs are paid by the drug company and will be recovered through the price paid for them.
At any one time EMA is using the collected experience and knowledge of over a thousand doctors and scientists in its review processes, over 35,000 each year. They come from 28 countries, many from the UK. The UK will only be able to use a fraction of that number, reducing the quality of each review. This increases risk for UK patients when using new drugs.
The UK does not have enough people to undertake reviews to the quality EMA delivers and in the volume it delivers them. A queue of new drugs will build up, delaying their introduction into clinical practice in the UK. Meanwhile in Europe they will be available.
A drug company will want its drug marketed in the largest market first. Thus its focus will be on the EMA rather than the UK. Some companies will see the UK as a sideline because there will now be two barriers to getting the drug to patients – MHRA covering the licensing of the drug and NICE looking at whether it is worth the NHS paying for it. It is anticipated that some companies, especially the smaller innovative ones, will have no interest in bringing new drugs to the UK.
Self-regulation by pharmaceutical companies is not an option. I won’t speculate on what that could mean in this situation.
Far from giving us greater control over our borders a potential reality of Brexit is a build up of risk to the healthcare of everyone in the UK, along with increased costs. The risk will grow over time, it could even kill people. The government will make a unilateral decision about what happens, it may not even get debated in Parliament. There will be no public consultation and quite possibly no consultation with independent healthcare experts, patient organisations or scientific and medical associations.